Mr X and Health Products Regulatory Authority

Whether the HPRA was justified in refusing access to records which relate to an application for authorisation to market a veterinary medicinal product

7 April 2020

Background

The applicant is the owner of a veterinary medicinal product. The applicant’s product was granted a period of data exclusivity. After this period passed, a competitor company submitted an application to the HPRA for market authorisation for a generic version of the product through the decentralised procedure which was granted.

Medicinal products which are intended for use in more than one EU member state can be authorised through a decentralised procedure which results in a harmonised national authorisation being issued by each member state party to the procedure. The national authorisation is given by the national competent authority of the member state, which is the HPRA in Ireland. I understand that the applicant is challenging the HPRA’s is decision in the Courts and those proceedings are ongoing.

In a request dated 19 March 2019, the applicant sought access to:

1. The bioavailability studies submitted by a pharmaceutical company to demonstrate the bioequivalence of a named veterinary product with a reference product;

2. The comparison of product composition submitted by a pharmaceutical company in respect of the two veterinary medicinal products;

3. All records relating to any consideration by the HPRA or competent authorities of the other Member States of whether the application for approval of the named veterinary product was properly submitted under the relevant EU Directive;

4. All records relating to any consideration by the HPRA of whether the named veterinary product is a biological veterinary product within the meaning of the relevant EU Directive;

5. All correspondence between the HPRA and the competent authorities of any other Member States relating to an application for a marketing authorisation in respect of the named veterinary product;

6. All metadata relating to the email allegedly sent by the HPRA on 30 October 2018 at 09:39 to a named party.

The HPRA formed the view that the release of certain records that fall within the scope of parts 3 and 4 of the applicant’s request would affect the interests of third parties and it engaged in a process of consultation with affected third parties under section 38 of the Act. On 27 May 2019, the HPRA issued its decision. It provided the applicant with a schedule of all of the records that fall within the scope of each part of the request. The HPRA refused access to records that fall within the scope of part 1 of the request on the basis that no such records exist. It refused access in full or in part to records that fall within the scope of parts 2 and 5 of the request under sections 35, 36 and 37 of the Act. It granted access to one record that falls within the scope of part 6 of the request. The HPRA stated that if the applicant wished to request a review of its decision in relation to those records, it can request an internal review.

The HPRA stated that it had carried out third party consultations under section 38 of the FOI Act in relation to the records marked with an asterisk under parts 3 and 4 of the request. It refused access to parts of those records under section 37 of the Act. The HPRA stated that if the applicant wished to request a review of its decision in relation to those records, it may apply directly to the Commissioner. The applicant applied directly to this Office for a review of the HPRA’s decision. My decision in that case under reference number OIC-53564-R8W8B1 will issue separately.

On 30 May 2019, the applicant requested an internal review of the HPRA’s decision in relation to the records that fall within the scope of parts 1, 2, 5 and 6 of its request. On 24 June 2019, the HPRA affirmed its original decision

On 6 September 2019, the applicant applied to this Office for a review of the HPRA’s decision in relation to the records that fall within the scope of parts 1, 2, 5 and 6 of the request. During the course of the review, this Office provided the applicant and the HPRA with an opportunity to make submissions. A number of new material issues arose on foot of the HPRA’s submissions. The HPRA provided pertinent search details not previously disclosed to the applicant in relation to its searches to locate records that fall within the scope of part 1 and 6 of the request. The HPRA also stated that as part of its ongoing court challenge, the applicant sought discovery of documents against the HPRA. It stated that there was significant overlap between the documents sought in discovery and the documents the subject matter of the FOI request. It stated that the High Court had determined that the documents sought are commercially sensitive and it argues that this decision is relevant to the considerations of the Commissioner in this case.

This Office provided the applicant with details of the new material issues which arose following the HPRA’s submissions and invited it to comment. In reply, the applicant agreed to exclude parts 1 and 6 of its request from the scope of this review. The applicant argued that the decision of the High Court is not relevant to the review by the Commissioner and it stated that this decision is under appeal.

I have now completed my review in accordance with section 22(2) of the FOI Act. In carrying out my review, I have had regard to the submissions made to date, I have also examined the records at issue. I have decided to conclude this review by way of a formal, binding decision.

Scope of the review

The scope of this review is confined to whether the HPRA was justified in refusing access in full or in part to the records which fall within the scope of parts 2 and 5 of the applicant’s request under sections 35, 36 or 37 of the FOI Act. On 15 July 2019, the HPRA wrote to the applicant and stated that during the course of its preparation of documents for this Office in relation to case OIC-53564-R8W8B1, it noticed discrepancies between the schedule of records and the released records. The HPRA stated that certain records which fall within the scope of part 5 of the request listed in the schedule as part granted were not included in the released records. The HPRA released these records. It also said that two additional records were located which it released in full or in part. The HPRA provided the applicant and this Office with copies of the records at issue together with an updated schedule and, for clarity, I confirm that those documents form part of the review by this Office.

Preliminary Matters

In its submissions, the applicant complained that the HPRA’s Schedule "does not provide sufficient detail of the nature of the documents for the applicant to determine the type of information contained within such documents. For example, stating that a document is an email between two parties does not provide any detail on what the email relates to. In such circumstances it is difficult to make detailed submissions relating to each and every document referred to in the schedule." The applicant requested that a more detailed schedule be furnished so that submissions can be made that are specific to each document.

This Office has no powers to compel an FOI body to create a schedule in any particular form. Nevertheless, this Office considers, as does the Guidance issued by the Department of Public Expenditure and Reform, that, in keeping with good administrative practice, an FOI body should generally provide a schedule of records which contains sufficient particulars to allow the requester to understand the FOI body's decision to refuse access to each record, whether in whole or in part. In my view, having regard to the need to protect exempt material from disclosure, it would not be appropriate for this Office to request the HPRA to provide a schedule detailing the subject matter of emails between it and the other competent authorities, in the context of comparing product composition or deciding whether to grant market authorisation. The applicant is a pharmaceutical company with expertise in the type of records created during comparison of product composition and during the marketing authorisation process. I am satisfied that the schedule contains sufficient particulars to allow the applicant to understand the nature and extent of the records identified as being held and the FOI body's decision and to make submissions to this Office.

Section 13(4) of the FOI Act provides that the actual or perceived reasons for a request must generally be disregarded by the decision maker, including the Information Commissioner, (except insofar as such reasons are relevant to consideration of the public interest or other provisions of the Act).

Section 18 of the Act provides for the deletion of exempt information and the granting of access to a copy of a record with such exempt information removed. This should be done where it is practicable to do so and where the copy of the record thus created would not be misleading. However, the Commissioner takes the view that neither the definition of a record nor the provisions of section 18 envisage or require the extracting of particular sentences or occasional paragraphs from records for the purpose of granting access to those particular sentences or paragraphs. Generally speaking, therefore, the Commissioner is not in favour of the cutting or "dissecting" of records to such an extent.

Although I am obliged to give reasons for my decision, section 25(3) requires all reasonable precautions to be taken in the course of a review to prevent disclosure of information contained in an exempt record. This means that the description which I can give of the background, the records at issue and the material that I can refer to in the analysis is limited. The release of a record under the FOI Act is considered, effectively, as release to the world at large.

The Records

The HPRA located six records which fall within the scope of part 2 of the request. It released the public assessment report which is available online and it refused access to the remaining records under sections 35 and/or 36 of the Act. The withheld records are Day 106 and Day 190 responses to lists of questions which contain the results of comparison of product composition.

The HPRA located 63 records which fall within the scope of part 5 of the request. It released two records and refused access in full or in part to the remaining records under sections 35, 36 or 37 the Act. The records include email correspondence between the HPRA and competent authorities of other member states in relation to the application for market authorisation. The HPRA partially released this email correspondence with the redaction of names, addresses and telephone numbers of individual staff members on the basis that this is the personal information of the individuals concerned and is exempt under section 37 of the Act. Many of the emails contain attachments which include lists of questions, the applicant’s responses to these questions, assessment of the responses, comments from member states and preliminary assessment reports. The HPRA have refused access in full or in part to these attachments on the basis that they contain confidential or commercially sensitive information and are exempt under sections 35 and or 36 of the FOI Act.

Section 36 – Commercially Sensitive Information

I will first consider the HPRA’s decision to refuse access in full or in part to records, which fall within the scope of parts 2 and 5 of the request, on the basis that they contain commercially sensitive information. The HPRA has sought to rely on sections 36(1)(a), (b) and (c) of Act in support of its decision. In my view, section 36(1)(b) is the most relevant exemption provision. Section 36(1)(b) applies to a record containing financial, commercial, scientific or technical or other information whose disclosure could reasonably be expected to result in a material financial loss or gain to the person to whom it relates or could prejudice the competitive position of that person in the conduct of his or her profession or business or otherwise in his or her occupation. Section 36(1) does not apply, however, if the public interest would, on balance, be better served by granting rather than by refusing the request (section 36(3) refers).

The essence of the test in section 36(1)(b) is not the nature of the information but the nature of the harm that might be occasioned by its release. The harm test in the first part of subsection (1)(b) is that disclosure of the information "could reasonably be expected to result in material financial loss or gain." The test to be applied in this regard is whether the decision maker's expectation is reasonable. The harm test in the second part of subsection (1)(b) is whether disclosure of the information "could prejudice the competitive position" of the person concerned. The standard of proof necessary to meet this test is considerably lower than the standard to meet the test of "could reasonably be expected to" in the first part of subsection 36(1)(b). However, the Commissioner takes the view that, in invoking "prejudice", the damage which could occur must be specified with a reasonable degree of clarity.

The HPRA states that an applicant seeking authorisation for a medicinal product must provide evidence that the product meets predefined standards of quality, safety and efficacy related to its proposed use and this evidence is provided in a dossier. According to the HPRA, the dossier contains the scientific tests that the generic company has undertaken on the materials that it has sourced to manufacture the medicinal product. The HPRA states that while, on the face of it, a generic product is the same as an originator, the generic can have different excipients and a different “version” of the same active ingredient. It states that where the active ingredient is supplied by a third party, this data is submitted directly to the HPRA and the applicant for authorisation does not see this data.

The HPRA states that the dossier submitted by the applicant outlines all the manufacturing steps, tests carried out and quantitative formulas used. It argues that releasing this data to a third party would allow that party to replicate the processes and buy ingredients from the same suppliers and develop their own product at a fraction of the cost that the generic manufacturer undertook to bring the product to the market. As outlined above, the HPRA also states that the High Court has recently determined that many of the records that fall within the scope of the applicant’s request are commercially sensitive.

The applicant states that the Information and Privacy Commissioner of Ontario has defined scientific information as:

“Information belonging to an organised field of knowledge in either the natural, biological or social sciences or mathematics. In addition, for information to be characterised as scientific information, it must relate to observations and testing specific hypothesis or conclusions and be undertaken by an expert in the field.” M. McDonagh, Freedom of Information Law, Third Edition at page 532

The applicant argues that the information sought in categories 2 and 5 of its request is not characterised as scientific information as there is no testing of hypothesis or conclusions as required by the above definition.

The applicant submits that the documents listed at part 2 of the schedule will indicate whether comparative testing took place and whether the generic product has the same qualitative and quantitative composition as the reference product which is a requirement under the relevant EU Directive. The applicant states that it is not the result of the comparison that is required but whether data was put before the HPRA and what type of testing was put forward. The applicant argues that the fact that comparative tests are easily obtained by conducting tests on the two products which are available on the market, means that the data sought could not be commercially sensitive and could not result in any loss to the competitive position of the generic company.

The applicant states that the Court of Justice of the European Union (CJEU) has rejected the contention that there is a general presumption that all documents submitted as part of a marketing authorisation application dossier are protected as commercially confidential. It argues that it is a matter for the HPRA to determine whether documents in its possession are genuinely commercially confidential, such that their release would undermine the commercial interests of third parties in a serious way and it argues that such concerns can generally be addressed by redaction. The applicant also submits that the test for commercial confidentiality in a discovery application, and the test for commercially sensitive information under the FOI Act are different. It states that commercial confidentiality does not prevent a judge from granting discovery. The applicant argues that the High Court did not reject the application for discovery on the basis of commercial confidentiality but instead the Court held that the documents sought were not “necessary” and “relevant” in order for the applicant to state its case to the court.

I accept that the decision of the High Court in relation discovery is under appeal. I also accept that there is no presumption that all of the relevant documents are commercially confidential. I have carefully examined the records which fall within the scope of parts 2 and 5 of the request which were refused in full or in part. The records which fall within the scope of part 2 of the request include the results of various tests carried out in relation to product composition. The records which fall within the scope of part 5 of the request contain information on trials and studies concerning the drug substance and the final pharmaceutical product, including pre-clinical studies, clinical trials and manufacturing and testing data. While it seems to me that an argument could be made that occasional sentences from the records could be released without prejudice to the company’s interests , having regard to the provisions of section 18 explained above, such redaction would not be practicable and would result in a misleading copy of the record.

I am satisfied that the information contained in parts 2 and 5 of the request is commercial, technical, scientific or other information of the type covered by section 36(1)(b) of the Act. In relation to the applicant’s reliance on the Ontario Commissioner’s definition, this is not binding on me and, in any case, it is not a requirement that a record must contain scientific information in order for the harm tests in section 36(1)(b) to be met. The withheld parts contain quality testing information, detailed descriptions of product composition and manufacturing processes. I accept that the generic company has invested in developing and obtaining authorisation for its generic product. I also accept that the information could be of use to competitors and that the generic company could lose sales, profits and market share if its competitors have access to the withheld information. I am satisfied, therefore, that release of the withheld information could prejudice the competitive position of the generic company and I find that the withheld information is exempt under section 36(1)(b) subject to the public interest balancing test provided for under section 36(3).

The Public Interest

Section 36(3) provides that subsection (1) does not apply in relation to a case in which, in the opinion of the head concerned, the public interest would, on balance, be better served by granting than by refusing to grant the FOI request. Section 36(1) itself reflects the public interest in the protection of commercially sensitive information. On the other hand, the Act also recognises, both in its long title and its individual provisions that there is a significant public interest in government being open and accountable. The Commissioner takes the view that, in attempting to strike the balance between openness on the one hand and the need to protect commercially sensitive information on the other, it is legitimate to consider two things: the first is the positive public interest which is served by disclosure and the second is the harm that might be caused by disclosure.

In relation to the harm which could be caused by disclosure, I have identified potential prejudice to the competitive position of the company. As a general principle, I do not believe that the FOI Act was designed as a means by which the operations of private enterprises were to be opened up to scrutiny.

As regards the public interest in transparency around the role of the HPRA, I note that following authorisation, a product is entered on the list of authorised products published on the HPRA website which includes a link to the Summary of Product Characteristics (SPC). I understand that the product label, package leaflet and where relevant any outer carton text are all agreed as part of the procedure and are available on product within the marketplace once the product is marketed. In addition, I note that the HPRA publishes the Public Assessment Report, after deleting any information of a commercially confidential nature and that it has published an assessment report in relation to its decision in this case which is available on its website. In my view, the European transparency rules serve the public interest in openness and accountability with respect to the HPRA’s regulatory processes in ensuring the safety, efficacy and quality of medicinal products while at the same time observing the public interest in the protection of commercially sensitive information. I am satisfied that the public interest would not, on balance, be better served by granting than by refusing to grant access to the withheld information.

In light of this finding, I do not consider it necessary to determine whether section 35(1) may also apply to the records or parts of records which were refused on the basis that they contain confidential information.

Section 37 - Personal Information

As outlined above, the HPRA also withheld information contained in email correspondence with other competent authorities and the generic company under section 37 of the Act. Section 37(1) of the Act provides that, subject to the other provisions of the section, an FOI body shall refuse a request if access to the record concerned would involve the disclosure of personal information. Section 2 of the Act defines "personal information" as information about an identifiable individual that, either - (a) would, in the ordinary course of events, be known only to the individual or members of the family, or friends, of the individual, or (b) is held by an FOI body on the understanding that it would be treated by that body as confidential. Section 2 of Act details fourteen specific categories of information that is personal without prejudice to the generality of the foregoing definition. These categories include (xii) the name of the individual where it appears with other personal information relating to the individual or where the disclosure of the name would, or would be likely to, establish that any personal information held by the FOI body concerned relates to the individual.

As outlined above, the information withheld from the emails contains names, email and postal addresses and telephone numbers for individual staff members in the competent authorities and in the generic company. I note that the HPRA did not redact the names of HPRA staff from the records, solely names of individuals external to the HPRA. I find that this information is exempt from release on the basis of section 37(1) subject to the consideration of sections 37(2) and section 37(5) which I examine below.

Section 37(2)

There are some circumstances, provided for at section 37(2) of the FOI Act, in which the exemption at section 37(1) does not apply. I am satisfied that none of the circumstances identified at section 37(2) (a), (b), (c), (d), or (e) arise in this case.

Section 37(5) The Public Interest

Section 37(5) provides that access to the personal information of a third party may be granted where (a) the public interest that the request should be granted outweighs the right to privacy of the individual to whom the information relates, or (b) the grant of the request would benefit the

person to whom the information relates. It has not been argued that releasing the records would benefit the persons to whom the information relates and I am satisfied that section 37(5)(b) does not apply in the circumstances.

In relation to paragraph (a), I must consider whether the public interest in granting the request outweighs, on balance, the public interest in protecting the right of privacy of the individuals to whom the information relates. The FOI Act itself recognises the public interest in ensuring the transparency and accountability of public bodies. On the other hand, however, the language of section 37 and the Long Title to the FOI Act recognise a very strong public interest in protecting the right to privacy, which has a Constitutional dimension, as one of the un-enumerated personal rights under the Constitution. Accordingly, when considering section 37(5)(a), privacy rights will be set aside only where the public interest served by granting the request (and breaching those rights) is sufficiently strong to outweigh the public interest in protecting privacy.

For similar reasons to those stated in relation to section 36(3), I am satisfied that European transparency rules serve the public interest in openness and accountability with respect to the HPRA’s regulatory processes in ensuring safety, efficacy and quality of medicinal products. I am not satisfied that the public interest in openness and accountability in respect of the HPRA’s functions would be further enhanced by the release into the public domain of names, addresses and telephone numbers of individuals employed by the generic company or competent authorities of other member states. I find, therefore, that the records do not fall to be released under section 37(5)(a) of the Act.

Decision

Having carried out a review under section 22(2) of the Freedom of Information Act, I affirm the HPRA’s decision in relation to the records withheld in full or in part under section 36 or 37 of the FOI Act.

Appeal

Section 24 of the FOI Act sets out detailed provisions for an appeal to the High Court by a party to a review, or any other person affected by the decision. In summary, such an appeal, normally on a point of law, must be initiated not later than four weeks after notice of the decision was given to the person bringing the appeal.